REDAPT 71354363Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556212998), received between Dec 10, 2019 and Dec 10, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K121627); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER PRIMARY HIP REPLACEMENT, PATIENT HAD INFECTION OF PROSTHETIC HIP JOINT AND SHELL, LINER, NECK AND FEMORAL HEAD WERE EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9448626 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121627. One submission often covers many models, so check the product and lot details in each record.

• Z-0944-2017 · Nov 15, 2016 · Terminated
  Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments